Regulatory Focus™ > News Articles > Regulatory Reconnaissance (16 October 2013)

Regulatory Reconnaissance (16 October 2013)

Posted 16 October 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • Novo Nordisk wins US approval for haemophilia treatment (PMLive) (Pharma Times) (Pharma Letter-$)
  • Supreme Court Won't Mull Hospira's Duty To Supply Drug (Law 360-$) (Pharmalot)
  • FDA's First "Breakthrough" Approval Coming; Won't Break Speed Records (RPM Report-$)
  • What Innovation Crisis? First-In-Class Drug Approvals Stable For Almost 25 Years, FDA Says (PAM-$)
  • Globus Medical reveals FDA warning letter over MicroFuse putty (Mass Device)
  • Beyond the Warning Letter: FDA Ups The Enforcement Ante for Supplements (NPI)
  • Warning and NOV Letter Summary - 3rd Quarter 2013 (Eye on FDA)

In Focus: International

  • Industry Official Warns Trial Transparency Push Could Delay EU Drug Applications (FDA News-$)
  • UK PM to urge speedy adoption of flexible drug licensing in EU (SCRIP-$)
  • A New Approach to Psychiatric Drug Approval in Europe (PLoS)
  • First qualification opinion on a statistical methodology for dose finding released for public consultation (EMA)
  • Treat the Chinese FDA With the Same Priority As You Would its U.S. Counterpart (MDDI)

US: Pharmaceuticals/Biotechnology

  • Novo Nordisk wins US approval for haemophilia treatment (PMLive) (Pharma Times) (Pharma Letter-$)
  • Supreme Court Won't Mull Hospira's Duty To Supply Drug (Law 360-$) (Pharmalot)
  • FDA's First "Breakthrough" Approval Coming; Won't Break Speed Records (RPM Report-$)
  • What Innovation Crisis? First-In-Class Drug Approvals Stable For Almost 25 Years, FDA Says (PAM-$)
  • Janssen's Topamax Users Blame Drug for Birth Defects (Bloomberg)
  • Pharma Innovation Is Highest Where It Matters Most, FDA Analysis Shows (PAM-$)
  • A Push to Sell Testosterone Gels Troubles Doctors (NYTimes)
  • An Outlook on Biosimilar Competition (Thomson Reuters)
  • The U.S. Battle of Biosimilars Continues on Multiple Fronts (BioWorld-$)
  • Advocacy, Drug, Pharmacy Groups Push Risk-Based REMS Approach (IHP-$)
  • The Essential Investor Guide to Amarin's Vascepa FDA Panel (The Street)
  • FDA Panel To Discuss "Breakpoint" Changes For Systemic Antibiotics (Pink Sheet-$)
  • Actavis seeks approval for generic opioid-dependence drug (DSN)
  • Gilead's Single Tablet HIV Regimen Stribild Demonstrates Durable Viral Suppression Through Three Years of Therapy (Press) (Pharma Letter-$)
  • Sanofi/Regeneron's alirocumab slashes cholesterol alone (Pharma Times) (NYTimes) (Pfizer)
  • FDA clears Eisai Zonegran facility in UK for US exports (Pharma Letter-$)

US: Pharmaceuticals and Biotechnology: General

  • Genzyme to invest $80 million to expand capacity for Fabrazyme (Pharma Letter-$) (BioFlash) (Press) (GEN)
  • Is The American Healthcare System Addicted To Expensive New Drugs? (Forbes)

US: Medical Devices

  • Globus Medical reveals FDA warning letter over MicroFuse putty (Mass Device)
  • FDA Exemption May Open Door For Doctors To Develop Mobile Apps (IHP-$)
  • Johnson & Johnson settles another DePuy ASR lawsuit (Mass Device)
  • Class 1 Recall for GE's Avance, Aespire View and Engstrom Anesthesia Devices (FDA) (FDA)
  • Crospon Receives FDA Approval for EsoFlip Dilation Catheter (MedGadget)
  • Crosstrees Receives 510(k) for Balloon-Free Device for Treatment of Vertebral Fracture (MDDI)

US: Dietary Supplements

  • Maker of Craze suspends production of sports supplement (USA Today)
  • Health Official: Consumers Reported Taking Recommended Dose of Supplements Linked to Hepatitis (NPI)
  • Beyond the Warning Letter: FDA Ups The Enforcement Ante for Supplements (NPI)

US: Assorted And Government

  • Everybody wants some: Firms prepare for data sharing (SCRIP-$)
  • Warning and NOV Letter Summary - 3rd Quarter 2013 (Eye on FDA)
  • The Randomized Clinical Trial at the 50th Anniversary of the Kefauver-Harris Amendments (Quintiles)
  • Federal health agencies vulnerable to cyberattack, study finds (GovHealthIT)
  • Vermont Fines 25 Manufactures for Violations of the Vermont Prescribed Product Gift Ban and Disclosure Law (Policy and Medicine)

Upcoming Meetings And Events

  • 16 October 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 16 October 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 17-18 October 2013: Anti-Infective Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 22-23 October 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA)
  • 24-25 October 2013: Antiviral Drugs Advisory Commitee Meeting (FDA) (Day 2)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Industry Official Warns Trial Transparency Push Could Delay EU Drug Applications (FDA News-$)
  • UK PM to urge speedy adoption of flexible drug licensing in EU (SCRIP-$)
  • A New Approach to Psychiatric Drug Approval in Europe (PLoS)
  • First qualification opinion on a statistical methodology for dose finding released for public consultation (EMA)
  • European Medicines Agency publishes report on sales of veterinary antimicrobials in 25 countries in 2011 (EMA)
  • New Authorization for NSCLC Drug Giotrif (afatinib) (EMA)

Asia

  • Treat the Chinese FDA With the Same Priority As You Would its U.S. Counterpart (MDDI)
  • Ouch! The Chinese Bribery Scandal Is Hurting Big Pharma (Pharmalot)
  • Guangdong FDA Fails 81 Drugs, Blacklists 4 Listed Pharma In 2Q Drug Evaluations (PharmAsia-$)

Other International

  • Health Canada Releases Guidance on Post-Notice of Compliance Changes to Quality (HC)
  • Australian Regulators Target Caffeine Combo Stimulants (Law 360-$)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #179 - 16 October 2013

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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